Patent Term Extension Case Law In Japan

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YUASA AND HARALAW, PATENT, TRADEMARK & DESIGN and ACCOUNTING


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AIPLA 2009 Annual MeetingIP Practice in Japan Committee － Pre-meeting

October 14, 2009

Koji Hirayama YUASA and HARA

[email protected]

Patent Term Extension:Case Law in Japan

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Life Cycle Management of Drugs

Introductory Period Growth Period Maturation Period Declining Period

Perform sales promotion activity

Sales decrease due to a drop in market share and price

Sales startHit the marketSales expand

Acquire profits to recoup research and development costs

time

sales

Profitability point

Patent TermEntry of Generic Drugs

Sales Authorization by Government

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Life Cycle Management of Drugs (cont’d)

Introductory Period Growth Period Maturation Period Declining Period

“Gross Sales”Authorization by Government

Entry of Generic Drugs

• How to Maximize “Gross Sales” ?

• Accelerate the start of sales by expediting authorization from government

• Delay the entry of generic drugs by “patent term extension”

“Gross Sales”Patent Term Extension

Expediting authorization

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Concept of Patent Term Extension

• If the patented invention could not be worked for the necessity of obtaining a marketing approval provided under legal regulations designed for ensuring product safety

Ex. Drug, Pesticide (Japan)

• Benefit of exclusive rights cannot be enjoyed despite the validity of patent rights.

• Such situations pose problems affecting the basis of the patent system, and a measure of extending the patent terms is necessary in order to resolve the situation.

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Patent Term Extension System

registrationdate

filing date clinicaltrial

startingdate

approval by government

20 yearsfrom

filing date

whicheveris later

extensionperiod

0 ＜ extension period 5 years≦

extensionperiod

Patent Term

working of the patent right prohibited

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US *1 JP *2

Products applicable for patent term extension

drugs, medical equipment,food additives, artificial

colorsdrugs, pesticides

Term to be extendedup to 5 yrs

(within 14 yrs from approval)up to 5 yrs

Patent(s) extendible based on one approval

only one patentchosen by applicant

one or more patents relating to approved

product

Number of times for one patent to be extended

only once no limitation

Effect of extended patent right

Limited to approved product, but including a later-approved

use

Limited to approved product and use

*1 35 USC §§155-156 *2 Japanese patent law §67bis

Brief Comparison – US v. JP

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“Multiple patents” corresponding to one approval

chemical substance patent

medical use A patent

production process patent

filingdate

filingdate

filingdate

time

patent term expires

patent term expires

patent term expires

extension period

extension period

extension period

All the patents individually extendible as long as there is a necessity to obtain an approval for the working of each of the patented inventions

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88

US *1 JP *2









product





use




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“Multiple approvals” corresponding to one patent

Chemical substance patent

patent term expires

filingdate

extension periodfor medical use A

extension period for medical use B

extension period5 years maximum

time

patent term20 years

Extension may be granted for each of the different medical uses

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1010

US *1 JP *2









product





use




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Statutory Requirements

• [T]here is a period during which the patented invention is unable to be worked because […] “[a] disposition designated by Cabinet Order” […] is necessary to obtain for the working of the patented invention… Section 67(2)• Marketing approval for drugs and pesticides

• What acts are covered by “the working of the patented invention” ?

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JPO’s Interpretation of Statutory Law

• In judging requirements for registration for extension, JPO considers “the scope of a patent right to be extended.”

• JPO’s Interpretation:• “product” “an active ingredient”• “use” “efficacy / effect”

• [An extended] patent right shall not be effective against any act other than the working of the patented invention for “the product” which was the subject of the approval […] (where the specific use of the product is prescribed by the disposition, the product used for that “use”). Section 68-2.

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JPO’s Practice and Court’s Precedents

• JPO’s Practice:• [W]hen approvals are granted to pharmaceuticals

with the same active ingredient (product) and the same efficacy / effect (use) and differing only in […] dosage forms, etc., patent term extension shall be granted on basis of the earliest approval only. Examination Guidelines Part IV 3-1-1(1)

• Court’s precedents upheld JPO’s practice.

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Extension Inapplicable to Later Approval


patent term expires

filingdate




later approval of dosage form of medical use B

time

patent term20 years

same active ingredientsame efficacy / effectdifferent dosage form

Extension is inapplicable to a later approval for dosage form if there is a preceding approval in which active ingredient and efficacy / effect are the same

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IP High Court Cases

• Three cases are brought before IP High Court, challenging appropriateness of JPO’s interpretation of law and Court’s precedents.

IP High Court (Tokyo High Court)

No. 2008-10458, -10459, -10460

(May 29, 2009)

(decided on the same day by Judge Iimura’s panel)

These cases are related to different patents.

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Preceding Approvalactive ingredient Aefficacy / effect Bdosage form C

Later Approvalactive ingredient Aefficacy / effect Bdosage form D

Patent Term Extension

• Takeda obtained two marketing approvals under the Pharmaceutical Affairs Law.

Facts in common among 3 cases

Takeda files an application forpatent term extension.

JPO examiner rejects the application due to an existence of the preceding approval .

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Case Preceding Approval Later Approval

2008-10458 Liquid / 5mg, 10mg Capsule / 30mg

2008-10459Injection solution

One-month sustained releaseInjection solution

Three-month sustained release

2008-10460 Liquid / 5mg, 10mg Capsule / 30mg

Facts – Details of Approvals

• Between preceding and later approvals,• Same active ingredient• Same efficacy / effect• Different dosage form

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• Should “the scope of a patent right to be extended” be considered in judging requirements for registration for extension ?

Issues of the Cases

• Should “the product” in Section 68-2 (defining the scope of a patent right to be extended) be interpreted as “an active ingredient” ?

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• Should “the scope of a patent right to be extended” be considered in judging requirements for registration for extension ?

Holding of the Cases

NO.

• Should “the product” in Section 68-2 (defining the scope of a patent right to be extended) be interpreted as “an active ingredient” ? NO.

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Holding of the Cases (cont’d)

• “product” means a product specified by “ingredient,” “amount,” and “structure” of the drug which is the subject of the disposition.

• “use” refers to a case of a use invention.

• To refuse an application for patent term extension, an examiner shall prove:• (i) that “the disposition designated by Cabinet Order”

does not dissolve prohibition of working of the patented invention; or

• (ii) that acts whose prohibition is dissolved by “the disposition designated by Cabinet Order” do not fall within acts of working of the patented invention.

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• Patent term extension may be applicable to a later approval of dosage form.

• Pharmaceutical company can recoup more investment.

Effect of the Cases


patent term expires




patent term20 years

later approval of dosage form of medical use B

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• IP High Court denies JPO’s interpretation of the statutory law.

• IP High Court vacates its own precedents.• Possible effects on Patent Law Reform

• Ministry of Economy, Trade and Industry (METI) has studied on possibility of reforming patent term extension system, but now stops proceeding of the study until the decisions of these three cases become conclusive and final.

Short Summary

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What comes the next ?

• JPO appeals to the Supreme Court• Need to pay attention to the progress before the S. Ct.

• Whether a writ of cert is granted• If granted, how the S. Ct. decides the cases

Trick or Treat !

Supreme Court

OR

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Thank you for your attention !

Koji Hirayama YUASA and HARA

[email protected]

Documents

Patent Term Extension Case Law In Japan